JDRF Announces New Initiative to Pave Way for Open Protocol Automated Insulin Delivery Systems

—Initiative encourages manufacturers to give users greater control over insulin devices;
JDRF to provide funding, support with regulatory, liability hurdles—

NEW YORK, October 18, 2017 —JDRF, the leading global organization funding type 1 diabetes (T1D) research, is announcing a new initiative that will support the development of open protocols for artificial pancreas (AP) technology.

For more than a decade, JDRF has played a leadership role in accelerating the development and commercialization of AP systems that automate insulin delivery, defining a roadmap for increasingly sophisticated systems that would, with each generation, improve outcomes and reduce burden for people with T1D. Now, the first commercial system, which has been shown to provide significant benefit to people with diabetes, is on the market, and other systems are in development.

At the same time, a thriving community of users has rallied behind a patient-driven ecosystem, using do-it-yourself (DIY) approaches. In such systems, continuous glucose monitors and insulin pumps are reverse engineered, allowing projects such as Nightscout, OpenAPS and Loop to display data in innovative ways or to control automated insulin delivery.

“To support innovation and enable type 1 diabetes families to use an open-protocol approach safely, we need to ensure the regulatory pathway is clear, and we will work with industry stakeholders to make devices compatible. By making this approach more accessible to a wider group of people with diabetes, users of insulin delivery devices will be able to manage their blood glucose levels better, and in a way that works best for them,” said JDRF Chief Mission Officer Aaron Kowalski, Ph.D.

This new initiative will explore ways to overcome potential challenges in the use and adoption of open-protocol systems, most notably helping to establish clear financial, regulatory and legal frameworks. JDRF will enlist various experts and allies as part of this initiative, which will be led by JDRF Research Director Daniel A. Finan, Ph.D., under the direction of Kowalski.

JDRF will be contributing resources, coordinating with regulators and legal advisors to develop a predictable pathway to FDA review, and encouraging device manufacturers to update communication protocols on their devices to enable seamless, secure connectivity with other devices (e.g., by using Bluetooth technology). While the technology exists and is well known, there are risks and other logistical hurdles that need to be overcome in order to give consumers access across systems.

JDRF believes that both proprietary and open-protocol development pathways can fuel innovation that improves outcomes and reduces the burden of T1D. JDRF is fully committed to continuing to support the development of traditional, proprietary commercial approaches, including both full AP systems and their individual components. At the same time, JDRF will also explore means to support the open-protocol ecosystem, with the goal of unlocking innovative and expedited pathways to market safely.

“JDRF is firmly committed to ensuring people with diabetes have access to tools that improve their lives as we drive towards a cure,” Dr. Kowalski said. “Automated insulin delivery systems are already benefiting people with type 1 diabetes, and open-protocol innovation is providing additional solutions. JDRF will explore means to ensure innovation continues at a rapid pace and that we tap the best people from diverse fields to support progress in this area.”

Automation of insulin delivery has been proven to provide significant benefit to people with diabetes and their loved ones. Numerous studies have shown reductions in HbA1c, hypoglycemia and hyperglycemia, as well as increases in time-in-range. Moreover, studies have demonstrated improvements in patient-reported outcomes (PROs) such as reduced anxiety, lessened fear of hypoglycemia and improved sleep.

Said JDRF International Board Member and Tidepool founding team member Brandon Arbiter, who was working as a data and intelligence analyst when diagnosed with T1D at the age of 27, “Do-it-yourself systems are innovating at a rapid pace and I, for one, have benefitted immensely from the community developing tools that leverage direct access to device protocols. It’s been game changing. There is a tremendous opportunity to leverage the expertise from skilled individuals from outside the traditional diabetes space in order to drive solutions to patients.” JDRF launched its Artificial Pancreas Project in 2006 to accelerate the development of commercial automated insulin delivery (closed-loop) systems. JDRF proposed a roadmap for multiple generations of systems, incorporating technological advances to improve outcomes and reduce the burden of T1D. Since then, JDRF has supported more than $100 million in research and development for AP technology. Key partners such as the National Institutes of Health and The Leona M. and Harry B. Helmsley Charitable Trust have made significant investments.

ABOUT T1D

Type 1 diabetes (T1D) is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. Its onset has nothing to do with diet or lifestyle. There is nothing you can do to prevent T1D, and — at present — nothing you can do to get rid of it.

ABOUT JDRF

JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.